NCT01751529

Brief Summary

This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound when used to evaluate renal lesions in two different populations; patients with known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort 2).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2013

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

2.5 years

First QC Date

December 13, 2012

Last Update Submit

March 15, 2017

Conditions

Kidney Cancer

Keywords

renal malignancyPilot StudyLCCC 1219UNC Linebergerkidney cancercontrast-enhanced ultrasoundultrasound

Outcome Measures

Primary Outcomes (1)

  • Feasibility of using contrast-enhanced ultrasound in diagnosing renal malignancy in patients with known renal disease (Cohort 1) and in patients with a risk factor for renal malignancy diagnosed with suspicious or indeterminate lesions (Cohort 2)

    Primary analyses will include 1) estimating the sensitivity of contrast enhanced ultrasound in Cohort 1 using the pathological outcome or biopsy result from ablative therapy as gold standard and 2) estimating sensitivity in Cohort 2 using pathology and follow-up results as gold standard (when tissue biopsy is not indicated nor surgery planned the truth standard diagnosis will be based on 12 month follow-up data of disease status). Exact 95% confidence intervals for sensitivity estimate will be reported.

    12 months

Secondary Outcomes (1)

  • Feasibility of comparing the sensitivity and specificity of contrast enhanced ultrasound to traditional imaging techniques (CT and MRI) in detecting renal lesions in patients already diagnosed with a renal malignancy

    12 months

Study Arms (1)

Contrast-enhanced Ultrasound

EXPERIMENTAL
Procedure: Contrast-enhanced UltrasoundDrug: Perflutren lipid

Interventions

Contrast-enhanced UltrasoundPROCEDURE

All patients will undergo a contrast-enhanced ultrasound prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.

Also known as: Contrast-enhanced US
Contrast-enhanced Ultrasound
Perflutren lipidDRUG

All patients will receive a contrast-enhanced ultrasound using microbubble contrast agent (perflutren lipid; Definity®) prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.

Also known as: Definity®
Contrast-enhanced Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to provide written informed consent
  • Willing to comply with protocol requirements
  • At least 18 years of age
  • Cohort 1:
  • Be eligible for radical or partial nephrectomy or ablative therapy based upon at least one renal lesion identified during previous contrast enhanced CT or MR.
  • Cohort 2:
  • High risk group (patient recommended for routine surveillance screening for renal malignancy)
  • Have at least one kidney lesion identified but incompletely characterized on a screening US, CT, or MR exam

You may not qualify if:

  • Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) requiring oxygen)
  • Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
  • Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure \>90mmHg), or adult respiratory distress syndrome
  • Active cardiac disease including any of the following:
  • Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
  • Unstable angina.
  • Severe arrhythmia (i.e. ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes).
  • Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
  • Uncontrolled systemic hypertension (Blood pressure: systolic blood pressure (BP) \>150 mm Hg and/or diastolic BP \>90 mm Hg despite optimal medical management not controllable by medication to achieve BP \<15/90)
  • Is in an intensive care setting
  • Has an unstable neurological disease (e.g recent stroke or TIA symptoms (\<3 months)) cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3 months before signing of informed consent
  • Undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery, nonsurgical cytoreductive procedure) in-between identification of lesion via US without contrast and perflutren lipid administration
  • Has previously been entered into this study or has received an investigational drug within the 30 days prior to admission into this study
  • Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:
  • Mental illness
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Chang EH, Chong WK, Kasoji SK, Fielding JR, Altun E, Mullin LB, Kim JI, Fine JP, Dayton PA, Rathmell WK. Diagnostic accuracy of contrast-enhanced ultrasound for characterization of kidney lesions in patients with and without chronic kidney disease. BMC Nephrol. 2017 Aug 9;18(1):266. doi: 10.1186/s12882-017-0681-8.

    PMID: 28793871DERIVED

Related Links

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Kimryn Rathmell, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

  • Wui Chong, MBBS, FRCR

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 18, 2012

Study Start

May 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 17, 2017

Record last verified: 2017-03

Locations

US(1)